The primary objective of this clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom and with a known core infarct volume at admission. The secondary objective is to determine if there is a correlation between infarct volume and functional outcome in treated patients at 90 days post-procedure.
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure
Timeframe: At 90 days post-procedure
Angiographic Assessment of Vessel Patency as Measured by TIMI Score
Timeframe: At immediate post-procedure
Angiographic Assessment of Vessel Patency as Measured by Modified TICI Score
Timeframe: At immediate post-procedure
Procedural Serious Adverse Events During the Procedure
Timeframe: During the procedure, approximately 24 hours